Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of sub-q and iv treprostinil in kids with pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: abstract this is a multi-center, open-label pharmacokinetic (pk) study examining the relationship between the steady-state plasma concentration and dose of treprostinil delivered intravenously or subcutaneously in children with pulmonary arterial hypertension (pah). subjects will be divided into 5 cohorts by age. a blood sample will be obtained from each subject at steady state. additional blood samples will be obtained from a small subset of subjects with a 15% increase or with at least a 15ng/kg/min increase in dose from steady state. samples will be sent to a pharmacokinetic laboratory for analysis. linear regression analysis will be used to determine the relationship between the steady state plasma concentration and drug dose. a power model will be used to assess dose proportionality.

background information and rationale treprostinil has not been adequately studied to determine its safety and efficacy in children ≤ 16 years old. however, the drug's use and tolerance in children with pah has been demonstrated in studies with small sample sizes. although the pharmacokinetic relationship of treprostinil has been established in adult patients with pah, the relationship between the steady-state plasma concentration and dose for children requires further investigation because of physiologic differences, such as the maturity of enzyme systems and drug clearance mechanisms, between children and adults. the subjects in this study will be divided into cohorts by age to address the physiologic changes that occur throughout childhood. currently, no data exists demonstrating the relationship between the steady-state plasma concentration and dose for children treated with intravenously or subcutaneously delivered treprostinil. understanding the pharmacokinetics of treprostinil among different age cohorts in children will provide the data to make an informed recommendation for dosing based on age (and possibly weight).

Eligibility criteria:
inclusion criteria: 1. patients must be on continuous intravenous or subcutaneous treprostinil for the treatment of pulmonary arterial hypertension, defined as mean pulmonary artery pressure \>25mmhg at rest with a pvri \> 3 wood units. 2. patients must be between the ages of 0 to 16 years at the time of study enrollment. 3. written informed consent and assent, when applicable, must be completed. exclusion criteria: 1. patients with severe liver or renal diseases. 2. female patients who may be pregnant or breastfeeding 3. written informed consent and assent not completed due to patient and/or parent or legal guardian unwilling to participate. 4. patients on concomitant use of a cyp2c inhibitor or inducer.

Keywords: pharmacokinetic analysis remodulin trepostinil pulmonary arterial hypertension
glucose monitoring during threatening preterm birth in patients with and without gestational diabetes mellitus

Conditions: Diabetes, Gestational; Insulin Sensitivity; PreTerm Birth; Glucose Intolerance During Pregnancy; Glucocorticoids

Summary: this study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

background: the therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance. therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child. gestational diabetes mellitus (gdm) is one of the most common complications during pregnancy, and the numbers are on the rise. gdm is characterized through an insulin resistance during the pregnancy. high blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth. methods: this study includes pregnant women with and without gestational diabetes who are medicated with betamethasone due to threatening preterm birth. in this study the blood glucose measurements of one week, as well as the measurements of hba1c, insulin and blood glucose from a blood draw one week after the lung maturation therapy will be considered.

Eligibility criteria:
inclusion criteria: * female * gestational age between 23+0 and 34+6 * an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group) * threatening preterm birth exclusion criteria: * missing consent to participate * age under 18 years * age over 50 years * preexistent diabetes (type 1 or 2) * apparent disease of the thyroid gland * infectious diseases as hiv or hepatitis c * insulin dependent gestational diabetes mellitus

Keywords: blood glucose monitoring glucose tolerance hba1c insulin betamethasone
epidemiological study to evaluate personality disorders in prison populations in treatment for hepatitis c

Conditions: Hepatitis C, Chronic; Personality Disorders in Prison

Summary: primary objective: evaluate the prevalence of personality disorders in patients starting treatment for hepatitis c in the prison and determine their influence on the evolution of the disease.

secondary objectives: * describe the management of patients with personality disorders on treatment for hepatitis c in the prison. * describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.

Eligibility criteria:
inclusion criteria: * patients 18 years of age. * patients with expected prison stay beyond the duration of follow-up period of the study. * patients with chronic hcv infection and detectable viral load to initiate treatment with standard therapy. * patients their written informed consent to participate in the study. exclusion criteria: * patients previously treated with interferon (ifn) and ribavirin (rbv). * patients can not read or understand a written questionnaire at the discretion of the investigator.

Keywords: prison, disorder, hepatitis c
clinical evaluation of 177lu-dota-eb-fapi in patients with various solid tumors

Conditions: Refractory Solid Tumor

Summary: increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. however, a major problem in the therapeutic use of 177lu-dota-fapi has been its short half-life and fast rate of clearance. this study was designed to investigate the efficacy and safety of 177lu-dota-eb-fapi in patients with various solid tumors who had failed standard therapies.

this investigator-initiated phase ii study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68ga-fapi-46 pet/ct. the fixed dose of 177lu-dota-eb-fapi is 3.3gbq (90 mci) per cycle. treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. the primary endpoint assessed the radiological response (according to recist criteria) after completion of radioligand therapy. the secondary endpoints included progression-free survival (pfs), overall survival (os), dosimetry, and safety of 177lu-dota-eb-fapi.

Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign a written informed consent document. * age 18 and older. * confirmed unresectable or metastatic refractory cancer with measurable disease per recist (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis). * progressive disease after multiple-lines treatment. * completion of entry into 68ga-fapi-46 study and completion of scan. the tumor lesions showing increased radiotracer uptake on 68ga-fapi-46 pet/ct (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions). * able to remain motionless for up to 30-60 minutes per scan. exclusion criteria: * serum creatinine level \>150 μmol/l. * hemoglobin level \ 3 times the upper limit of the normal range and serum albumin level \<2.0 g/dl. * participants with class 3 or 4 nyha congestive heart failure. * participants with severe allergy, or hypersensitivity to radiographic contrast material. * participants with claustrophobia. * pregnant or lactating women.

Keywords: refractory solid tumor radioligand therapy 177lu-dota-eb-fapi
lumbar spinal fibrosis and tnf alpha inhibition

Conditions: Post Operative Sciatica by Lumbar Spinal Fibrosis

Summary: tnf-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. inhibiting tnf-alpha could significantly decrease spinal fibrosis after lumbar discectomy.

object: failed back surgery syndrome is still a challenging therapeutic problem. clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy and the recurrence of radicular pain in 25% of cases. forceful epidural infiltrations, radiotherapy, therapy with d-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the t1 sequence and a hypersignal in t2 sequence around the spinal tissue. tumor necrosis factor a (tnf-a) is the main cytokine implicated in the formation of tissue fibrosis. in animal models of fibrosis, tnf-a inhibition has been shown to prevent and treat tissue fibrosis. hypothesis: inhibiting tnf-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis. methods: we propose a 2-year pilot prospective, randomized, double-blind, controlled study of tnf-a inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal fibrosis. the infliximab group will receive one intravenous injection of 3 mg/kg infliximab. the control group will receive one physiological serum injection. patients will be evaluated at day 0, 10, 30, 90, and 180. the main evaluation criterion will be sciatica pain as measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10. this objective leads to a size of 20 patients per group. the other evaluation criteria will be clinical, functional, social, and professional. patients will be recruited from the rehabilitation unit at cochin teaching hospital.

Eligibility criteria:
inclusion criteria: * age over 18 years old * sciatica post discectomy * pain with vas \> 40 mm and impossibility to have his usual activity * surgical discectomy (less than 2 years and more than 6 months) * painless of more than one month and less than one year after the discectomy * mri with gadolinium injection of less than 6 months and done more than 6 months after the discectomy * presence of spinal fibrosis on mri (hyposignal in t1 enhanced by gadolinium and hypersignal in t2) * failure of epidural injection treatment * absence of tuberculosis * contraception for woman * informed consent exclusion criteria: * chronic psychiatric pathologies not treated * presence of conflict between nerve root and herniated disc or disc fragments or spinal stenosis * severe cognitives troubles * severe cardiac failure (class iii or iv) * tuberculosis (active or latent), severe infections * cancers * allergy reactions to the drug studied * difficulties to understand french * patients enrolled in another clinical trial in the past three months * pregnancy, breastfeeding or no contraception

Keywords: sciatica pain tnf-alpha discectomy fibrosis spine
self medication with oral morphine after total knee arthroplasty.

Conditions: Arthroplasty, Knee Replacement; Pain Control

Summary: the study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. the investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.


Eligibility criteria:
inclusion criteria: * patients requiring total knee replacement surgery willing to provide written, informed consent. exclusion criteria: * unable to safely self medicate. allergy to morphine. unable to provide consent. contraindication to the standardised anaesthetic or standard postoperative care. not consenting to an element of the standardised anaesthetic. pre-operative use of strong opiates e.g. oramorph, mst, oxynorm.

Keywords: knee replacement pain control self medication
the effects of hydrocortisone in endotoxemia in normal volunteers

Conditions: Infections

Summary: corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. hydrocortisone is a man-made form of this substance. endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. this study is designed to give hydrocortisone before and after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the endotoxin.

the body's immune response to injury otr infection is very complex. immune cell activity, the release of specific mediators (such as proteins), genetics (deoxyribonucleic acid or dna) and/or the body's "instructions" for making proteins (ribonucleic acid or rna) may effect the body's clinical response to a stress such as an infection.hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. this study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.in addition, this study may determine whether any of the above(proteins,dna,rna,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. this will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Eligibility criteria:
inclusion criteria: * general good health as demonstrated by medical history, physical\& laboratory tests * age between 18 and 40 years * written informed consent prior to the performance of any study related procedures exclusion criteria: * history of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension * any medication taken in past 48 hrs (except birth control) * recent history of alcohol or drug abuse * unable to provide written informed consent * exposure to any experimental agent or procedure within 30 days of study * pregnant or breast-feeding

Keywords: immune system
efficacy study of tempol to prevent hair loss from radiotherapy to the brain

Conditions: Alopecia

Summary: hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. in this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. the goal is to determine to what extent the experimental drug is successful in lessening the hair loss.


Eligibility criteria:
inclusion criteria: * metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended. * hair that covers the scalp and is at least 1/4 inch in length exclusion criteria: * receiving chemotherapy known to cause alopecia within 60 days of study or during the study. * pre-existing alopecia * previous brain radiotherapy * scalp metastases or scalp wounds * use of hair dyes

Keywords: alopecia hair loss radiation whole brain radiotherapy radiation-induced alopecia
single and multiple dose escalation study to assess the safety and tolerability of cjm112 in psoriasis

Conditions: Chronic Plaque-type Psoriasis

Summary: a randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of cjm112 in chronic plaque-type psoriasis patients. this trial never made it to the phase ii part of this trial.


Eligibility criteria:
inclusion criteria: * men or women 18-65 years of age at time of consent * chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization * at randomization, moderate to severe psoriasis as defined by: * pasi score of 12 or greater and, * iga score of 3 or greater and, * body surface area (bsa) affected by plaque-type psoriasis of 10% or greater. * female patients may be included according to the following: women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment. • male subjects must agree to comply with two highly effective contraceptive methods exclusion criteria: * forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis) * ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. washout periods detailed in the protocol have to be adhered to * previous treatment with il-17 or il17r blocking agents, including secukinumab * any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of cjm112 or secukinumab * evidence of active tuberculosis at screening * active systemic infections (other than common cold) * pregnant or nursing (lactating) women

Keywords: psoriasis, chronic plaque-type psoriasis, il17, monoclonal antibody
a study to evaluate the single-agent lenalidomide in subjects with recurrent non-small-cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. subjects will continue until disease progression is documented.


Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign an informed consent form. 2. age \>or = to 18 years at the time of signing the informed consent form 3. able to adhere to the study visit schedule and other protocol requirements 4. must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. those regimens must have contained both a platinum compound and a taxane either sequentially or in combination 5. subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter. 6. eastern cooperative oncology group (ecog) performance status score of 0 or 1 (see appendix ii). 7. women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test within 7 days of starting study drug. in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. wcbp must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. exclusion criteria: 1. any of the following laboratory abnormalities: 1. absolute neutrophil count (anc) \<1,500 cells/mm3 (1.5 x 109/l) 2. platelet count \<100,000/mm3 (100 x 109/l) 3. serum creatinine \>2.5 mg/dl (221 mmol/l) 4. serum sgot/ast or sgpt/alt \>5.0 x upper limit of normal (uln) 5. serum total bilirubin \>2.0 mg/dl (34 mmol/l) 2. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 3. prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year. 4. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 5. pregnant or lactating females. 6. prior \> or = grade 3 allergic reaction/hypersensitivity to thalidomide. 7. prior \> or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide. 8. prior use of lenalidomide. 9. use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.

Keywords: celgene cc-5013 nsclc cc5013 revlimid non-small cell lung cancer
evaluation of primary plating in sternotomy patients for osteosynthesis and pain

Conditions: Sternal Wound Infection; Sternal Non-union; Pain; Mediastinitis

Summary: the goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.

median sternotomy patients will be randomized to either wire or rigid fixation groups. a scheduled evaluation period will record clinical parameters. enrollment has ended with one hundred forty (140) patients.

Eligibility criteria:
inclusion criteria: * patients undergoing median sternotomy; * patients eighteen (18) years of age or older; * patients presenting two or more risk factors such as diabetes mellitus, chronic obstructive pulmonary disease, obesity (bmi \> 30), osteoporosis, renal failure, chronic steroid use, immunosuppression, redo sternotomy, neurologic dysfunction severely affecting ambulation, * off mid-line sternotomy * bilateral ima use * long cardio-pulmonary bypass runs * transverse fractures of the sternum exclusion criteria: * patients with a non-standard sternotomy; * patients with an off-midline sternotomy that reduced the bony margin to \<2mm * patients under eighteen (18) years of age; * patients that are pregnant or currently lactating; * patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation, * patients defined within the new york heart association (nyha) or canadian cardiovascular society (ccs) functional class iv for congestive heart failure, * patients presenting emergent/salvage cardiac acuity as defined per the society of thoracic surgeons (sts) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia; * patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy); * patients unwilling or unable to return for follow-up; * lacking the ability to follow instructions; * intraoperative death.

Keywords: open heart surgery